CVS Health pushes for review of cholesterol management guidelines as "expensive" PCSK9 inhibitors enter market

In a commentary published Monday in JAMA, the CVS Health Research Institute urged that current guidelines for the management of high cholesterol be reconsidered in light of the introduction of "high-cost" PCSK9 inhibitors, which "could complicate treatment choices and inhibit utilisation management tools to manage costs." The FDA recently cleared Sanofi and Regeneron Pharmaceuticals' PCSK9 inhibitor Praluent (alirocumab), whose list price is about $14 600 a year, while an agency advisory committee has recommended Amgen's anti-PCSK9 therapy Repatha (evolucumab). CVS Health chief medical officer Troyen Brennan suggested the pharmacy benefits manager [PBM] may choose to cover only one of the drugs in order to secure a lower price, adding that a decision would be made after the FDA rules on Repatha later this month.

The authors of the JAMA commentary pointed out that unlike new hepatitis C drugs, such as Gilead Sciences' Sovaldi (sofosbuvir), which "shocked the healthcare system because of the high cost and relatively large eligible population," PCSK9 inhibitors do not represent a cure and are intended for long-term use, and as such, most payers "should begin to consider thoughtful ways to rationalise the use of these medications." CVS Health previously estimated that the PCSK9 inhibitor class could increase healthcare spending in the US by up to $150 billion a year.

According to William Shrank, chief scientific officer at CVS Health, "as PCSK9 inhibitors become available, the current cholesterol management guidelines do not provide clarity as to how these expensive new medications could fit in the treatment paradigm," noting that in some cases a prescriber might consider the drugs even for low-risk patients. Shrank suggested PCSK9 inhibitors will "likely be the most costly class of medications we've seen thus far," and that it is necessary to reach a "consensus around management strategies for patients with high cholesterol given that the cost differential between proven older therapies and this new class of drugs is substantial."

The current guidelines issued by the American Heart Association and the American College of Cardiology in 2013 abandoned the earlier focus on specific LDL cholesterol target levels in favour of a broader assessment of the patient's cardiovascular disease risk. At the time, some analysts suggested the new guidelines could more than double the number of patients receiving statin therapy, while slowing the uptake of drugs that are not statins, including PCSK9 inhibitors.

Brennan remarked that "as we work to encourage cost-effective use of these new cholesterol-lowering medications for our PBM clients, guidelines that incorporate specific LDL targets would be important to help determine where PCSK9 inhibitors best fit." He added that "given the changing market dynamics, we are encouraging an evaluation of treatment guidelines that will provide clear guidance for clinicians and will also enable effective utilisation management programmes to help control health care costs while achieving desired health outcomes."

Express Scripts' chief medical officer Steve Miller agreed that more specific guidance is necessary. "The question is how you define [statin] failure" he said, adding "there is a lot of ambiguity in the current classification system." Miller also indicated that Express Scripts may cover only one PCSK9 drug if the approach yields a better price. Meanwhile, American College of Cardiology president Kim Allan Williams argued that numerical targets are not needed as the guidelines already clarify that high doses of statins alone are expected to reduce LDL cholesterol by about 50 percent.

For related analysis on the PCSK9 inhibitor class, see Physician Views Poll Results: How do doctors see Praluent and Repatha stacking up after FDA panel meetings? See also ViewPoints: Regeneron, Sanofi seek leverage via Praluent's aggressive US pricing.

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